2002 Safety Alert - Camptosar (irinotecan hydrochloride injection) |
May 10, 2002
Dear Healthcare Professional:
Pharmacia is pleased to share recent changes in the prescribing information for CAMPTOSAR indicated as a component of therapy for first-line treatment of metastatic colorectal cancer in combination with 5-fluorouracil (5-FU) and leucovorin (LV) and for treatment of metastatic colorectal cancer that has recurred or progressed following initial 5-FU based treatment.
The labeling changes for CAMPTOSAR arose following the recommendations made at a December 6, 2001 meeting of the Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC). This committee was convened to review all available safety data for the combination regimen of CAMPTOSAR plus bolus 5-FU/LV. Consistent with ODAC's unanimous conclusions, FDA has agreed with the following:
Regimen
|
Drugs
|
Starting Doses
|
Cycle Schedule
|
Bolus
|
Irinotecan LV 5-FU |
125 mg/m2 IV over
90 minutes 20 mg/m2 IV bolus 500 mg/m2 IV bolus |
Weekly for 4 weeks in 6-week cycles |
Infusional
|
Irinotecan LV 5-FU |
180 mg/m2
IV over 90 minutes 200 mg/m2 IV over 2 hours 400 mg/m2 IV bolus, then 600 mg/m2 IV over 22 hours |
Day 1 Day 1, 2 Biweekly x3 in 6-week cycles Day 1, 2 |
The prescribing information has been revised to identify patients at higher risk of severe toxicity, to clarify dose modification guidelines, and to augment the information about management of treatment--related toxicities. The principal changes are as follows:
Pharmacia is committed to the safety and well being of all patients receiving CAMPTOSAR. If you have any questions, please contact your local Pharmacia representative or the Pharmacia Medical and Drug Information 24-hour hotline at 1-800-323-4204 or via the Pharmacia Oncology Web site (www.pharmaciaoncology.com).
Sincerely,
Langdon Miller, MD
Vice President, Clinical Research Oncology, US
Please see enclosed full prescribing information for CAMPTOSAR
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